Senior Drug Safety Physician

Locations: Bengaluru | Hyderabad | Mumbai | Pune | Delhi NCR

Work Mode: Hybrid

Experience: 3–6 Years

Qualification: MBBS – Mandatory

Key Responsibilities:

Medical review and assessment of ICSRs, including seriousness, listedness and causality. Review case narratives, coding, labeling, medical history and supporting documents. Perform medical sign-off and quality review of safety cases. Support literature surveillance and safety data analysis. Contribute to aggregate safety reporting, safety assessments and risk management activities. Ensure compliance with global Pharmacovigilance regulations, SOPs and quality standards. Collaborate with stakeholders and provide medical expertise and guidance.

Requirements:

MBBS with valid NMC/MCI registration and eligibility to practice in India. 3–6 years of relevant Pharmacovigilance/Drug Safety experience, including medical review of ICSRs. Hands-on experience with Argus Safety and/or ARISg preferred. Strong understanding of global drug safety processes, regulatory requirements and medical assessment of adverse events. Good knowledge of safety databases, PV processes and compliance requirements. Strong analytical, critical-thinking and communication skills. High attention to detail with a strong focus on quality and timelines.